Search Results

Medtronic Surgical Instruments are intended to be used during preparation and placement of Medtronic implants during spinal surgery to assist in precisely locating anatomical structures in either open, or minimally invasive, procedures. Medtronic Surgical Instruments are specifically designed for use with the Mazor X Stealth™ Edition. which is indicated for medical conditions in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a skull, a long bone, or vertebra can be identified relative to a CT or MR-based model, fluoroscopy images, or digitized landmarks of the anatomy. Medtronic Surgical Instruments can be navigated or non-navigated manual instruments that may or may not be guided through the Mazor X Stealth™ Edition Arm Guide. Medtronic surgical drills shall only be used through the Mazor X Stealth™ Edition arm guides, Medtronic cannulas, and Medtronic drill guides. Some of the Medtronic Surgical Instruments are also compatible with the IPC™ Powerease™ System or AO* style quick connect drilling motors. An instrument may incorporate a measuring function which has uses as described on the instrument. Medtronic cannulas may or may not be used with Midas Rex™ attachments and tools.

The Catalyft™ PL Expandable Interbody System navigated instruments consist of an Inserter (Outer), Inserter Inner Sleeve, Trials, a NAV Verification Tool, and Navigated Rotating Shavers that were cleared in K210425. These instruments are navigated instruments manufactured from stainless steel and are currently cleared for use in procedures where the use of stereotaxic surgery may be appropriate with the StealthStation™ System (K050438. S.E. 06/02/2005; K201189. S.E. 05/29/2020). Per this 510(k) submission, Medtronic is seeking clearance of the subject devices to also be navigated with MAZOR X™ (K182077, S.E. 11/02/2018; K203005, S.E. 10/27/2020) with the devices remaining compatible with StealthStation™ System.

Please note that the Navigated Rotating Shavers were previously cleared for use on MAZOR X™ (K203005, S.E. 10/27/2020), and per this 510(k) submission, the Rotating Shavers can be used for disc prep and to trial for Catalyft™ PL on MAZOR XTM.

The Anteralign™ TL navigated instruments consist of an Inserter and Trials that were originally cleared in K212524. These instruments are navigated instruments manufactured from stainless steel and are currently cleared for use in procedures where the use of stereotaxic surgery may be appropriate with the StealthStation™ System (K050438, S.E. 06/02/2005; K201189, S.E. 05/29/2020). Per this 510(k) submission, Medtronic is seeking clearance of the subject devices to also be navigated with MAZOR X™ (K182077, S.E. 11/02/2018; K203005, S.E. 10/27/2020) with the devices remaining compatible with StealthStation™ System.

The CD Horizon™ Solera™ Vovager™ Spinal System navigated instruments consists of new Drivers, which will be manufactured from stainless-steel. Medtronic is seeking clearance of the Drivers to be Navigated and Trajectory Guided via MAZOR X™ (K182077, S.E. 11/02/2018; K203005, S.E. 10/27/2020) and Powered via IPC™ POWEREASE™ System (K111520. S.E. 10/26/2011: K123270. S.E. 01/11/2013). To enable trajectory guidance compatibility, the Drivers have been designed to work with the MAZOR X™ Arm Guides. To enable power, the Drivers may also be attached to the POWEREASE™ Driver (K111520, S.E. 10/26/2011).

The provided document is a 510(k) summary for Medtronic surgical instruments, outlining their substantial equivalence to predicate devices. It focuses on the compatibility of these instruments with the MAZOR X™ system. However, the document does not contain the detailed acceptance criteria and performance data typically found in a clinical study report for proving a device meets acceptance criteria.

Specifically, it mentions "Performance Testing" and "Discussion of the Performance Testing" but then lists generic test descriptions rather than specific quantitative acceptance criteria or reported device performance metrics. There is no information on sample sizes, ground truth establishment, expert qualifications, or MRMC studies.

Therefore, based solely on the provided text, I cannot fill out the requested table or provide the detailed study information. The document serves as a high-level summary for regulatory submission, not a detailed performance study report.

Here's a breakdown of what can and cannot be extracted from the provided text according to your request:

Information NOT available in the provided text:

• A table of acceptance criteria and the reported device performance: The document lists general "performance testing" but does not define quantitative acceptance criteria (e.g., "accuracy shall be within X mm") or specific numerical results.
• Sample sizes used for the test set and the data provenance: No information on the number of cases, images, or subjects used in the "performance testing," nor any details on whether it was retrospective or prospective, or data origin.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as there's no mention of a ground truth established by experts for performance evaluation. The "ground truth" here is likely engineering validation against design specifications or a simulated environment, not clinical expert consensus.
• Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable; no human adjudication described.
• If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is surgical navigation instrumentation, not an AI / image analysis device that would assist human readers in diagnosis.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. The "performance testing" described is likely functional verification of the instruments and their compatibility with the navigation system, not a standalone algorithm performance.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not explicitly stated, but inferred to be engineering specifications and simulated use assessments rather than clinical ground truth.
• The sample size for the training set: Not applicable as this is not an AI/ML device that requires a training set.
• How the ground truth for the training set was established: Not applicable.

What can be inferred or extracted (though still lacking detail for your specific request):

• Device Type: Surgical Instruments for spinal surgery, intended to assist in precisely locating anatomical structures using navigation systems (MAZOR X™ Stealth™ Edition and StealthStation™ System).
• Nature of "Performance Testing": The document briefly lists categories of testing:
  • Navigation Accuracy Analysis
  • CAD Model Verification
  • Tools Package Functional Verification
  • NAV Simulated Use
  • Anatomical Simulated Use
• Purpose of Testing: "To ensure the functionality and compatibility of the identified Medtronic products when used with the Mazor X™ system."
• Conclusion: Based on the supporting information (which includes the performance testing), the subject instruments are deemed "substantially equivalent" to the predicate devices. This implies they met internal benchmarks/acceptance criteria, but the specific values are not provided.

In summary, the provided document is a regulatory submission summary demonstrating substantial equivalence, not a detailed technical report of the performance studies with acceptance criteria and results for the device's navigation accuracy or other functionalities.

Ask a specific question about this device